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  • 1.  EU Guidance surrounding Pediatric Medical Devices

    This message was posted by a user wishing to remain anonymous
    Posted 13-Jul-2020 11:19
    This message was posted by a user wishing to remain anonymous

    Hello,

    Is anyone familiar with an EU guidance that discusses pediatric medical devices? I haven't been able to find one, only been able to find guidance surround pediatric drugs.

    Thanks,
    Sarah


  • 2.  RE: EU Guidance surrounding Pediatric Medical Devices

    Posted 14-Jul-2020 01:47
    Hi Anon,

    Maybe you mean this one? "Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use"

    I am not aware of something particularly for Medical devices.

    Hope that helps​

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    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
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  • 3.  RE: EU Guidance surrounding Pediatric Medical Devices

    Posted 14-Jul-2020 03:35
    Hello,

    I am with Spyros, I am not aware of any guidance for paediatrics regarding medical devices.  There is information related to medicinal products and some other information in ICH, but not aware of anything medical device related - especially for the EU.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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